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Opioid Development Strategies In Pediatrics To Get FDA Advisory Panel Help

 
• By Michael Cipriano

While FDA has long required pediatric analgesic studies, very few sponsors have managed to complete them, mainly due to enrollment challenges; advisory committees will offer recommendations on other designs that may bring a more successful result.

Three of FDA’s advisory committees will come together to help the agency shore up its guidelines on pediatric opioid development, with only a few sponsors conducting pediatric analgesic studies in spite of long-time requirements to conduct such studies.

The Division of Anesthesia, Analgesia and Addiction Products (DAAAP) in the Center for Drug Evaluation and Research (CDER) for years has required pediatric opioid analgesic development include pharmacokinetic studies,

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